# K253974: Roosin Collagen Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Roosin Medical Co., Ltd.
- Decided: Jun 3, 2026 after 174 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913023 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122325: Skintemp II, Human Biosciences, Inc. (2012) Summary page 5.

## Indications for use
Roosin Collagen Dressing is intended for the management of burns, sores, blisters, scrapes, ulcers, and other wounds.

Source page: https://510kreport.com/device/K253974
Methodology: https://510kreport.com/methodology